This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers
Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Week 1 50mg orally BID
Week 2 100mg orally BID
Week 3+ 150mg orally BID
University of Illinois
Chicago, Illinois, United States
RECRUITINGIowa Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
RECRUITINGOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGIncrease the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days
Time frame: Day 84
How many days with Grade 2 or greater of diarrhea in the first month
Number of days with Grade 2 or greater in the first month
Time frame: 1 month
Rate of Grade 3 or greater of diarrhea in the first 3 months
Nuber of subjects who experienced Grade 3 or greater by the total number of subjects enrolled
Time frame: 3 months
Disease Free Survival (DFS)
Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death
Time frame: 1 year
Disease Free Survival (DFS)
Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from D1 of treatment until death
Time frame: 1 year
Overall Survival (OS)
OS is defined as the time from D1 of treatment until death
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from D1 of treatment until death
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Time frame: 3 years
Subject reported outcomes regarding adverse events
Toxicity grade as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 5 years